Osilodrostat for Blood Sugar Control in Type 2 Diabetes With Mild Excess Cortisol
Tests osilodrostat against placebo in adults with hard-to-control type 2 diabetes and mild excess cortisol.
Plain-language title generated from the registry record
Registry title: Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Key facts
- Where
- Basel, SwitzerlandSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with mild autonomous cortisol secretion (MACS) and type 2 diabetes that is hard to control. It tests whether osilodrostat improves blood-sugar control over 12 weeks.
- Age
- 18 to under 75 years (up to 74 years).
- Sex
- All sexes can join.
- Disease stage
- Confirmed MACS with a benign-looking adrenal gland finding on CT or MRI, and morning serum cortisol above 300 nmol/L. Type 2 diabetes with HbA1c above 7.0% (53 mmol/mol) despite several diabetes or blood-pressure medicines, or insulin, or diabetes complications.
- Earlier treatment
- Diabetes and other medicines must have been stable for at least 4 weeks before the first study visit. No systemic glucocorticoid therapy within 3 months.
- Biomarker or test result
- Serum cortisol above 50 nmol/L after a 1 mg dexamethasone suppression test, with low ACTH and DHEAS. Morning serum cortisol above 300 nmol/L. HbA1c above 7.0% (53 mmol/mol).
Main reasons for not taking part
- Type 1 diabetes, or diabetes diagnosed less than 1 year ago
- Malignant adrenal tumour, or adrenal surgery planned before the study ends
- Pregnancy or breastfeeding
- Severe kidney problems, dialysis, or liver cirrhosis Child-Pugh B or C
- Severe heart disease, QTc above 480 ms on ECG, or uncontrolled blood pressure of 160/100 mmHg or higher
Read by machine on 13 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 74 years old?
Source: NCT07922148, who can take part
Where in Switzerland
- University Hospital Basel, Clinic of Endocrinology, Diabetology & MetabolismBasel, SwitzerlandContact: Beckey Trinh, PD, MD, PhDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beckey Trinh
- Trial code
- NCT07922148
- Record updated
- 6 November 2026
- Original description
This single-centre, randomized, double-blind, placebo-controlled phase 2 trial investigates whether lowering cortisol with osilodrostat improves blood-glucose control in adults with mild autonomous cortisol secretion (MACS) and difficult-to-control type 2 diabetes. Forty-four participants are randomly assigned 1:1 to osilodrostat or matching placebo, taken once daily for 12 weeks, together with a blinded hydrocortisone/placebo for stress (sick-day) dosing. The primary outcome is the change in HbA1c from baseline to week 12; secondary outcomes include continuous glucose monitoring (CGM) metrics, cardiometabolic parameters, cortisol measures and quality of life. Participants are followed for a safety visit 4 weeks after the end of treatment.Read full original descriptionShow less
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
This single-centre, randomized, double-blind, placebo-controlled phase 2 trial investigates whether lowering cortisol with osilodrostat improves blood-glucose control in adults with mild autonomous cortisol secretion (MACS) and difficult-to-control type 2 diabetes. Forty-four participants are randomly assigned 1:1 to osilodrostat or matching placebo, taken once daily for 12 weeks, together with a blinded hydrocortisone/placebo for stress (sick-day) dosing. The primary outcome is the change in HbA1c from baseline to week 12; secondary outcomes include continuous glucose monitoring (CGM) metrics, cardiometabolic parameters, cortisol measures and quality of life. Participants are followed for a safety visit 4 weeks after the end of treatment.
Inclusion: Age 18 to <75 years; Confirmed MACS per ESE 2023 guidelines: serum cortisol >50 nmol/L after 1 mg dexamethasone suppression test, low ACTH and DHEAS, and uni-/bilateral adrenal adenoma(s) or macronodular/micronodular/diffuse bilateral adrenal hyperplasia on CT or MRI; Morning serum cortisol >300 nmol/L; Difficult-to-control type 2 diabetes: HbA1c >7.0% despite one of - ≥3 glucose-lowering medications; insulin plus ≥1 glucose-lowering medication; ≥2 glucose-lowering medications and ≥1 micro-/macrovascular complication; or ≥2 glucose-lowering and ≥2 blood-pressure-lowering medications; Stable background pharmacotherapy for ≥4 weeks before the first study visit; For persons of childbearing potential: agreement to abstinence or contraception with a failure rate ≤1%/year during treatment and for 1 month after the last dose.
Exclusion: Systemic glucocorticoid therapy within 3 months, or planned use; Current/recent intake of medications affecting adrenal steroidogenesis or cortisol assessment; Severe cardiovascular disease (NYHA class III-IV heart failure, myocardial infarction or unstable angina within the previous 6 months, or clinically significant arrhythmia); Known hypersensitivity to osilodrostat, its excipients, or the placebo; Malignant adrenal tumour; Type 1 diabetes; new-onset diabetes (<1 year); Severe psychiatric, medical or surgical illness; Uncontrolled arterial hypertension (≥ 160/100 mmHg despite therapy); Uncontrolled thyroid disease; History of breast or endometrial carcinoma; Concomitant therapy with clinically relevant drug-drug interactions with osilodrostat (strong CYP3A4 inhibitors; strong CYP3A4/CYP2B6 inducers; QT-prolonging medicinal products); Severe renal impairment (eGFR < 30 mL/min/1.73 m²), hemodialysis or end-stage renal disease; Refractory hypokalemia or hypomagnesemia (not correctable to K ≥4.0 and Mg ≥1.0 mmol/L before first dose); QTc > 480 ms on baseline ECG, or known congenital long QT syndrome; Age ≥75 years (osilodrostat not sufficiently studied in this age group per the SmPC); Planned adrenalectomy before completion of the study; Participation in another interventional trial within the last 30 days; Pregnancy or breastfeeding; WOCBP unwilling to use highly effective contraception; Excessive alcohol consumption; severe untreated sleep apnea; night-shift work; Liver cirrhosis Child-Pugh B or C.